HANCOCK® HC15020Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00681490908795), received between Nov 30, 2018 and Feb 19, 2021 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2021Degraded; Degraded

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 6 MONTHS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IN A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 25MM CONDUIT OF THE SAME MODEL. THE CONDUIT WAS REPLACED DUE TO LEAFLET DEGENERATION RESULTING IN WIDE-OPEN PULMONARY INSUFFICIENCY. THERE WAS ALSO "SOME STENOSIS" REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS RELATED TO THIS PULMONARY VALVED CONDUIT WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 11355428 ↗
• InjuryFeb 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 6 MONTHS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IN AN (B)(6)-YEAR-OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 25MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11266502 ↗
• InjuryOct 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS POST IMPLANT OF THIS 20 MM PULMONARY VALVED CONDUIT IN A (B)(6)-MONTH-OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE VALVE WAS REPLACED DUE TO SEVERE REGURGITATION. OF NOTE, IT WAS REPORTED THAT WHEN THE CONDUIT WAS ORIGINALLY IMPLANTED, THE SURGEON REMOVED THE STEEL SUPPORTING RING FROM THE CONDUIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Regurgitation

  MAUDE report 10662477 ↗
• InjuryAug 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 25MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10469906 ↗
• InjuryApr 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 6 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT IMPLANTED IN AN APPROXIMATELY (B)(6) PATIENT, A TRANSCATHETER PULMONARY VALVE (TPV) WAS IMPLANTED VALVE-IN-VALVE DUE TO STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 9961073 ↗
• InjuryOct 18, 2019Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 9 MONTHS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Endocarditis; No Information; Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 9207685 ↗
• InjuryFeb 26, 2019Calcified; Device Appears to Trigger Rejection; Insufficient Device Problem Information; Calcified; Device Appears to Trigger Rejection; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IMPLANTED IN A SIX YEAR PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 25MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; No Information; Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 8370323 ↗
• InjuryFeb 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 5 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT IN A (B)(6) YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE DUE TO SEVERE CONDUIT STENOSIS AND SUPRA-SYSTEMIC RIGHT VENTRICLE (RV) PRESSURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: High Blood Pressure/ Hypertension; Pulmonary Valve Stenosis

  MAUDE report 8332704 ↗
• InjuryNov 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS 4 MONTHS POST IMPLANT OF THIS 20MM BIOPROSTHETIC VALVED CONDUIT IN THIS PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER PULMONARY VALVE (TPV) FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8121340 ↗